MULTI-LUMEN CV CATH KIT AK 14703 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-02 for MULTI-LUMEN CV CATH KIT AK 14703 N/A manufactured by Arrow International: Precision Biomed.

Event Text Entries

[1314] Retained guidewire. Date of actual retention unknown at this time. Patient has had two (2) central lines placed. One on 7/16/92 on a previous admission. The x-ray does not note a retained wire. The patient had another placed 8/12/92. While reading the x-ray for placementdevice labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1671
• MDR Report Key: 1671
• Date Received: 1992-11-02
• Date of Report: 1992-10-20
• Date of Event: 1992-08-12
• Date Facility Aware: 1992-10-06
• Report Date: 1992-10-20
• Date Reported to FDA: 1992-10-20
• Date Reported to Mfgr: 1992-10-13
• Date Added to Maude: 1992-11-09
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MULTI-LUMEN CV CATH KIT
• Generic Name: CENTRAL LINE
• Product Code: GBP
• Date Received: 1992-11-02
• Model Number: AK 14703
• Catalog Number: N/A
• Lot Number: UNKNOWN
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1587
• Manufacturer: ARROW INTERNATIONAL: PRECISION BIOMED

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-11-02